Influenza studies create unique clinical supply demands

In a clinical supplies project for an influenza study, the Distribution Project Manager’s job can become something of a juggling act. Dropping the ball could jeopardize a study that potentially helps millions. Perfect execution is essential but the process can be complicated. In one example this involved up to 35 daily shipments that required temperature management, next day delivery to global distribution points and, the most challenging, little to no advance notice

The Unique Demands of Influenza Studies

In general, most clinical supplies projects work like this:

The clinical trial team identifies a set population and sets up a timeline that dictates when enrollment of patients will begin and end.

Patients typically set appointments and receive several tests.

The team analyzes the results and makes a determination, over time, whether the patient is a good candidate for enrollment in a study.

Investigational drug quantities are determined by the number of patients who are expected to enroll, and then clinical supply shipments are refined based on actual enrollment.

Influenza studies do not work that way. Flu outbreaks can cause a thousand people at a time to fall ill—or only 10 people. Patients suffering from flu symptoms only have to be tested for a particular strain needed for the study the day they visit a site. If a patient tests positive for the strain, that person can be enrolled immediately. This means that a patient could walk through the door of a site, get the test done, and walk out with the study drug the same day. That is, if they have the drug.

Clients are often working with minimal quantities of the study drug. When a site draws down to one clinical supply kit, they need more kits to arrive immediately – the next day. There are days when a clinical team might activate 30 to 35 site orders in one day. The clinical teams want the orders to go out that day—or yesterday if possible. On those days when the “we need it now” orders come in, the risk of jeopardizing the influenza studies can be palpable.

Operational Execution and Excellence

When requests come in from various sites they are all expedited and rush shipments that require immediate input to the distribution centers system.

Each order must contain the study drug along with a temperature-monitoring device in a special clinical supplies shipper with a client-specific pack-out design.

Because of the global distribution points, requisite shipping paperwork must be created to ensure there are no issues with customs clearance.

All of this requires more coordination, more timing, and more checking on the part of the Distribution Project Manager to ensure same-day processing and next-day delivery. Important considerations that can help ensure success:

Given the short to no notice on the inbound requests, it is essential that the distribution center retains sufficient stock of the required shipper materials and data loggers.

Detailed Standard Operating Procedures are a must to eliminate any guessing games that might introduce delays.

A well trained staff, teamwork, and a culture of service provide that intangible and invaluable ingredient for success.

At the end of the day it’s all about meeting a patient’s needs. Zero impact. Immeasurable benefit.

Review some important planning recommendations for scaling global vaccine trials.

Elizabeth is a seasoned pharmaceutical professional with experience and in-depth knowledge of clinical supplies packaging, labeling and distribution. Before joining Fisher Clinical Services, she was Director of Clinical Supply Operations for Daiichi Sankyo Pharma Development, the U.S. Research and Development operation of the global pharmaceutical company Daiichi Sankyo, Inc.
Her prior experience includes Director of Clinical Logistics at ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company. Elizabeth also worked in Johnson & Johnson’s Consumer Health and Biopharmaceutical divisions where she held a number of positions of increasing responsibility in clinical supplies throughout her successful 20-year career.